A Safety Study of an Oral EGFR Inhibitor, AV-412, Administered Three Times Weekly in Advanced Solid Tumor Patients

Completed · Phase 1

Conditions studied: Advanced Cancer, Refractory Cancer

In brief

The Epidermal Growth Factor Receptor (EGFR) is a validated target for the treatment of cancer, and agents targeting EGFR such as erlotinib (Tarceva®) are approved by the FDA for treatment of various solid tumors. AV-412 is a novel inhibitor of the EGFR-tyrosine kinase, with added activity against Her2 and other oncogenic kinases. Based on evidence of preclinical activity in various solid tumors, AV-412 is being developed as a possible novel treatment for cancer in humans. PURPOSE: The purpose of this study is to test the safety and tolerability of AV-412, and determine the maximum tolerated dose of AV-412 when administered orally three times weekly.

Key facts

Study ID: NCT00551850
Run by: AVEO Pharmaceuticals, Inc.
People needed: 37
Starts: 2007-10-01
Expected to finish: 2010-05-01
Last updated by the study team: 2011-10-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Ability to give written informed consent
18 years and older
Evaluable disease or measurable disease according to RECIST.
Subjects enrolled in the MTD Cohort B must have the following:
A diagnosis of non-small cell lung carcinoma (NSCLC)
Received prior therapy with erlotinib or gefitinib for a minimum of 12 weeks
Demonstrated disease stabilization or an objective response during that prior treatment
Evidence of disease progression and measurable disease, according to RECIST
Histologically confirmed solid tumor malignancy that is locally advanced or metastatic
Disease that is currently refractory to, or not amenable to, standard therapy and/or subjects who are unwilling to try standard chemotherapy
Disease that is currently not amenable to surgical intervention, due to either medical contraindications or non-resectability of the tumor
Karnofsky performance status ≥ 70%
Life expectancy ≥ 3 months, as judged by the investigator
No childbearing potential; or use of a medically acceptable form of contraception during the study through the end of follow-up period

You may not qualify if…

Pregnant or lactating women
Primary CNS malignancy and/or active CNS metastases (or leptomeningeal disease) not controlled by prior surgery or radiotherapy
Hematologic malignancies (including leukemia of any form, lymphoma, and multiple myeloma)
Active second malignancy or history of another malignancy within 2 years with the exception of:
Treated, non-melanoma skin cancers
Treated carcinoma in situ (CIS) of the breast or cervix
Controlled, superficial carcinoma of the bladder
T1a or b prostate carcinoma comprising < 5% of resected tissue, with prostate specific antigen (PSA) within normal limits (WNL) since resection
Any of the following hematologic abnormalities:
Hemoglobin ≤ 9.0 g/dL
ANC ≤ 1500 per mm3
Platelet count ≤ 75,000 per mm3
Any of the following serum chemistry abnormalities:
Total bilirubin > 1.5 × the ULN
AST or ALT ≥ 3 × ULN (≥ 5 × ULN if due to hepatic involvement by tumor)
Serum albumin < 2.5 g/dL
Creatinine ≥ 1.5 × ULN
Significant cardiovascular disease or condition, including:
Congestive heart failure requiring therapy
Ventricular arrhythmia requiring therapy
Severe conduction disturbance (including QTc interval prolongation > 0.47 sec [corrected], history of a severe arrhythmia, or history of a familial arrhythmia [eg, Wolff-Parkinson-White syndrome])
Angina pectoris requiring therapy
Left ventricular ejection fraction (LVEF) < 50% by MUGA or echocardiogram
Uncontrolled hypertension (as determined by investigator)
Myocardial infarction (MI) within 6 months prior to administration of first dose

Where it is running

Georgetown University Hospital — Washington D.C., District of Columbia, United States
Kansas Masonic Cancer Research Center — Kansas City, Kansas, United States
Dana-Farber Cancer Institute — Boston, Massachusetts, United States
Montefiore Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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